CTIS2024-514083-31-00进行中（未招募）1 期
INTERACT-ION : Ezabenlimab (BI 754091) and mDCF (docetaxel, cisplatin and 5-fluorouracil) followed by chemoradiotherapy in patients with stage III squamous cell anal carcinoma. A phase II study.
Centre Hospitalier Regional Universitaire0 个研究点目标入组 55 人开始时间: 2024年7月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Signed and dated informed consent,, 6.Locally advanced disease defined as: •Stage III (TxN1 or T4N0) Lymph node can be considered positive if one of the following criteria is satisfied: •Enlargement (largest short-axis diameter > 1 cm for mesorectal nodes, and > 1.5 cm for other nodes) OR, •Heterogeneity or necrosis OR, •Irregular contours OR, •Strong enhancement at magnetic resonance imaging (MRI) OR, •Positivity on positron emission tomography (PET) scan,, 7.Patient eligible to the mDCF regimen,, 8.Computed tomography (CT) scan performed within 30 days prior inclusion,, 9.MRI of pelvis performed within 30 days prior inclusion,, 3.Ability to comply with the study protocol in the Investigator’s judgment,, 10.PET scan performed within 30 days prior inclusion,, 11.Adequate hematologic and end-organ function: defined by the following laboratory test results obtained within 7 days prior to initiation of study treatment:, 12.Serum albumin ? 25 g/L (2.5 g/dL),, 13.For patients not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (PTT) ? 1.5 ? ULN,, 14.Patient affiliated to or beneficiary of French social security health insurance system (PUMA; La protection Universelle Maladie)., 2.Age =18 years,, 4.Performance status ECOG-WHO = 1,, 5.Histologically proved squamous cell anal carcinoma,
排除标准
- •1.Previously received chemotherapy or pelvic radiotherapy,, 10.Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and chronic obstructive pulmonary disease,, 11.Diabetes with vascular or neurovascular complications,, 12.Preexistent peripheral neuropathy or impaired audition,, 13.HIV positive patient with CD4 count under 400/mm3 (HIV test is mandatory before inclusion),, 14.Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total HBV core antibody (HBcAb) test at screening, are eligible for the study. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test,, 15.Active tuberculosis,, 16.Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, ketoconazole, etc.,, 17.Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5-FU, mitomycin, capecitabine) and dihydro pyrimidine dehydrogenase (DPD) complete deficit,, 18.Uncontrolled infection or another life-risk condition,, 19.Known hearing impairment that contraindicates cisplatin administration,, 2.Previously received anti-tumor immunotherapy (HPV vaccination is allowed),, 20.Administration of a (attenuated) live vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,, 21.Administration of prophylactic phenytoin,, 22.Inadequate laboratory values: MDRD CrCl < 60 ml/min, neutrophil count < 1500/mm3, platelets < 100.000/mm3, bilirubin 2.5 x ULN, AST/ALT 2.5 x ULN,, 23.Previous major surgery (requiring general anesthesia) within 28 days of enrollment., 24.Any immunosuppressive therapy (i.e. corticosteroids > 10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy,, 25.Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed,, 26.Prior allogeneic bone marrow transplantation or prior solid organ transplantation,, 27.Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed,, 28.Previously received an anti-PD-1, anti-PD-L1, or anti-CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) agent,, 29.Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Ezabenlimab (BI 754091) formulation,, 3.Metastatic disease,, 30.History of colorectal inflammatory disease,, 31.History of idiopathic or secondary pulmonary fibrosis (History of radiation pneumonitis in the radiation field fibrosis is permitted), or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy., 32.History of severe hypersensitivity reactions to other mAbs, 33.History of Chronic colorectal inflammatory disease (Ulcerative colitis, Crohn's disease),, 34.History of connective disease,, 35.History of autoimmune diseases., 4.Diagnosis of ad
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